Some of the products require the submission of a classification application to a Classification Committee of the Ministry of Health which convenes once every few months. GALI AMIR Regulatory Services LTD experts can ensure you a smooth and rapid classification process, especially in the most complex cases of classifications.
Registration and Renewal of Medical Device Approval
Apparatus and medical devices are under review of the Medical Devices Division in the Ministry of Health. Our company specializes in the submissions of medical devices and apparatus, new submissions as well as renewal of registered ones.
Preparation of Submissions of Cosmetics and Medical Devices for the Palestinian Authority
For the Palestinian Authority, the requirements for submissions are different from those of the Israeli Ministry of Health. GALI AMIR Regulatory Services LTD assists and provides the preparation of cosmetic products and medical devices dossiers for the Palestinian Authority, as well as a close guidance and accompaniment until licenses are obtained. The Palestinian Authority’s Ministry of Health requires documents that are different from those submitted in an Israeli application, so it is very important to be accompanied by the experienced professionals
Clinical Tests for Cosmetics and Medical Devices
For skin contact products which are approved as local-use cosmetics or medical devices, a clinical trial with volunteers is required. We, at GALI AMIR Regulatory Services LTD, we partner with the top laboratories in Europe that will provide the best results for these tests: tested for sensitive skin, dermatologically tested, ophthalmologist tested, hypoallergenic, sun protection and all according to the requirements of the Israeli Ministry of Health.
Over 20 years of expertise in regulations
A team of experts for regulation, pharmaceuticals, medical accessories and consumer products
Multilingual staff: Hebrew, English, Russian, French, Arabic and Ukrainian
Efficiency, professionalism, and reliability
Parallel import process subject to a free import order
Permits and licenses for the export of goods from Israel to any country in the world
Registration of medical preparations and accessories
Supply of licenses and approvals for the various products
